Location: Switzerland - Meyrin/Geneva
Function: Regulatory Affairs
Company: OM Pharma
We are currently looking for a Regulatory Affairs Manager for our OM Pharma site in Geneva to coordinate regulatory affairs activities for the products under responsibility; mainly for the region of Switzerland and EU. You will report directly to the Regulatory Affairs Team Lead Infectious Disease /OTX and your responsibilities will include, but are not be limited to:
- Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for the following regions: EU, Switzerland and US
- Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities
- Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
- Collaboration with the CMC, Regulatory International and Regulatory groups to ensure appropriate planning and timely execution of the regulatory activities
- Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
- Ensure compliance of dossiers with legislation and with the general requirements in EU and CH
- Coordinate the maintenance of up-to-date Modules 4, 5 and SmPC/PIL documentation according to international guidelines for products under responsibility
- Support regarding preparation and handling of Aggregate Safety Reports (PBRER, RMP…) according to internal procedures for products under responsibilities
- Represent regulatory affairs in relevant Project Teams (e.g. CMRST)
- Interact/entry contact point with Regulatory authorities, partners and consultants
- Interface with other departments on a national and international level
- Ensure tracking tools and regulatory databases are maintained up to date
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criteria:
- Scientific or Medical degree (pharmacy, chemistry or, biochemistry)
- Min. 7 years experience in Regulatory in Europe and Switzerland within a pharmaceutical company (experience in US would be an asset)
- Good knowledge and appropriate interpretation of guidelines, directives etc.
- Fluent in English, French (German would be an asset)
- Strategic thinking and acting, strong analytical and entrepreneurship skills
- Self-assertion, creative, solution-oriented work approach
- Accuracy, flexibility, open minded, team spirit, organised, autonomous
- Strong adaptability and excellent communication and negotiation skills
- Demonstrated ability to manage and lead projects successfully, interacting with senior stakeholders from different departments
You describe yourself as a solution oriented and flexible person who enjoys working in an intercultural environment. Your work is characterized by it’s accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.